Medical system for annuloplasty

Abstract

An annuloplasty device is disclosed for treating a defective mitral valve having an annulus, comprising a removable and flexible elongate displacement unit for temporary insertion into a coronary sinus (CS) adjacent the valve, wherein the displacement unit has a delivery state for delivery into the CS, and an activated state to which the displacement unit is temporarily and reversibly transferable from said delivery state, the displacement unit comprises a proximal reversibly expandable portion, a distal anchoring portion being movable in relation to the proximal expandable portion in a longitudinal direction of the displacement unit to said activated state in which the shape of the annulus is modified to a modified shape, wherein the proximal expandable portion is reversibly foldable to an expanded state for positioning against a tissue wall at the entrance of the CS.

The invention claimed is: 
     
       1. An annuloplasty device for treating a defective mitral valve having an annulus, comprising
 a removable and flexible elongate displacement unit for temporary insertion into a coronary sinus (CS) adjacent the valve, wherein the displacement unit has a delivery state for delivery into the CS, and an activated state to which the displacement unit is temporarily and reversibly transferable from said delivery state, the displacement unit comprises
 a proximal reversibly expandable portion and 
 a distal anchoring portion being movable in relation to the proximal expandable portion in a longitudinal direction of the displacement unit to said activated state in which the shape of the annulus is modified to a modified shape, wherein the proximal expandable portion is reversibly foldable to an expanded state for positioning against a tissue wall at the entrance of the CS, 
 
 wherein the elongate displacement unit comprises a lumen extending in the longitudinal direction and having a distal opening arranged distally of the distal anchoring portion, and at least one proximal opening arranged between the distal anchoring portion and the proximal expandable portion and 
 wherein an annular wall surrounds the lumen and the at least one proximal opening extends through the annular wall so that a direction of fluid flow through the lumen is from the distal opening through the at least one proximal opening. 
 
     
     
       2. The annuloplasty device according to  claim 1 , wherein the at least one proximal opening comprises an elongated shape extending along the longitudinal direction. 
     
     
       3. The annuloplasty device according to  claim 1 , wherein the least one proximal opening has an oval or ellipsoid shape being elongated along the longitudinal direction. 
     
     
       4. The annuloplasty device according to  claim 1 , wherein a cross-section (C) of the lumen, in a plane having a normal (N) parallel with the longitudinal direction, has a center point concentrically aligned with respect to a surrounding annular wall of the elongate displacement unit,
 the at least one opening extending through the annular wall over a width corresponding to a circle sector of the annular wall with respect to the center point, 
 wherein an angle (v, v′) of the circle sector with respect to the center point is less than 45 degrees. 
 
     
     
       5. The annuloplasty device according to  claim 4 , wherein an angle (v) of the circle sector is less than 30 degrees. 
     
     
       6. The annuloplasty device according to  claim 1 , wherein the distal opening has an area (A D ) to be exposed to a flow of fluid towards the distal opening,
 wherein a capacity of fluid flow through the at least one proximal opening from the lumen corresponds at least to said flow of fluid towards the distal opening. 
 
     
     
       7. The annuloplasty device according to  claim 6 , wherein a total area (A T ) exposed to a flow out from the lumen is equal to summed individual area (A, A′) of the at least one proximal opening, wherein the total area is more or equal to the area (A D ) to be exposed to a flow of fluid towards the distal opening. 
     
     
       8. The annuloplasty device according to  claim 1 , wherein
 the at least one proximal opening extends between a proximal edge and a distal edge in the annular wall, along the longitudinal direction, 
 wherein the proximal edge and/or distal edge is tapered along the longitudinal direction. 
 
     
     
       9. The annuloplasty device according to  claim 8 , wherein the proximal edge is tapering towards the distal opening. 
     
     
       10. The annuloplasty device according to  claim 9 , wherein the proximal edge tapers towards a proximal tip,
 the proximal edge extends between an inner surface and an outer surface of the annular wall, the inner surface facing the lumen, 
 the inner surface extends essentially in parallel with the longitudinal direction until reaching the proximal tip. 
 
     
     
       11. The annuloplasty device according to  claim 8 , wherein the distal edge is tapering towards the proximal edge. 
     
     
       12. The annuloplasty device according to  claim 11 , wherein the distal edge tapers towards a distal tip,
 the distal edge extends between an inner surface and an outer surface of the annular wall, the inner surface facing the lumen, 
 the outer surface extends essentially in parallel with the longitudinal direction until reaching the distal tip. 
 
     
     
       13. The annuloplasty device according to  claim 11 , wherein the distal edge is tapering towards a blunt distal tip. 
     
     
       14. The annuloplasty device according to  claim 1 , wherein the distal anchoring portion comprises an inflatable unit. 
     
     
       15. The annuloplasty device according to  claim 1 , wherein the proximal expandable portion comprises expandable bows extending in the longitudinal direction. 
     
     
       16. The annuloplasty device according to  claim 15 , wherein the expandable bows are connected to a sheath and are configured to be expanded in a radial direction, perpendicular to the longitudinal direction, by pushing a proximal portion of the sheath towards the distal anchoring portion. 
     
     
       17. The annuloplasty device according to  claim 15 , wherein the bows comprise elongated ribs formed in the sheath by elongated cuts in the sheath, extending in the longitudinal direction. 
     
     
       18. The annuloplasty device according to  claim 15 , wherein the bows are placed equidistantly around a circumference of the sheath. 
     
     
       19. The annuloplasty device according to  claim 15 , wherein, when the proximal expandable portion is folded to the expanded state, the bows extend with a curvature forming an apex positioned at a maximum expanded diameter (D) of the proximal expandable portion, whereby each of the bows extend with two expanded sections towards the apex, wherein the two expanded sections comprises a proximal expanded section and a distal expanded section, the distal expanded section is configured to be arranged against said tissue wall at the entrance of the CS, wherein at least a portion of the distal expanded section extends in a first direction forming a first angle (v 1 ) with the radial direction, and at least a portion of the proximal expanded section extends in a second direction forming a second angle (v 2 ) with the radial direction, wherein the first angle is less than the second angle. 
     
     
       20. The annuloplasty device according to  claim 19 , wherein the first direction is substantially parallel with the radial direction. 
     
     
       21. The annuloplasty device according to  claim 15 , wherein, when the proximal expandable portion is folded to the expanded state, the bows extend with a curvature forming an apex positioned at a maximum expanded diameter (D) of the proximal expandable portion, wherein the maximum expanded diameter (D) of the proximal expandable portion is at least three times the diameter of the CS. 
     
     
       22. The annuloplasty device according to  claim 21 , wherein a ratio of the maximum expanded diameter (D) of the proximal expandable portion to the diameter of the CS is in the range 3-5. 
     
     
       23. The annuloplasty device according to  claim 1 , comprising a guide wire arranged to extend inside the lumen and to exit the lumen at the distal opening. 
     
     
       24. The annuloplasty device according to  claim 14 , wherein the elongate displacement unit comprises at least one radiopaque marker arranged inside the inflatable unit. 
     
     
       25. The annuloplasty device according to  claim 14 , comprising an inflation lumen connected to inflatable unit and configured to deliver an inflation medium to the inflatable unit. 
     
     
       26. The annuloplasty device according to  claim 1 , wherein a distance (L) between the proximal expandable portion and the distal anchoring portion in the longitudinal direction decreases to a reduced distance (L′) when the displacement unit is transferred from the delivery state to the activated state. 
     
     
       27. A medical system for treating a defective mitral valve having an annulus, said system comprising, in combination:
 an annuloplasty device for treating a defective mitral valve having an annulus, said annuloplasty device comprising 
 a removable and flexible elongate displacement unit for temporary insertion into a coronary sinus (CS) adjacent the valve, wherein the displacement unit has a delivery state for delivery into the CS and an activated state to which the displacement unit is temporarily and reversibly transferable from said delivery state, 
 wherein the displacement unit comprises 
 a proximal reversibly expandable portion, 
 a distal anchoring portion being movable in relation to the proximal expandable portion in a longitudinal direction of the displacement unit to said activated state in which the shape of the annulus is modified to a modified shape, wherein the proximal expandable portion is reversibly foldable to an expanded state for positioning against a tissue wall at the entrance of the CS, and wherein the elongate displacement unit comprises a lumen extending in the longitudinal direction and having a distal opening arranged distally of the distal anchoring portion, and at least one proximal opening arranged between the distal anchoring portion and the proximal expandable portion so that a direction of fluid flow through the lumen is from the distal opening to the at least one proximal opening, and 
 an annuloplasty implant for permanent fixation at the mitral valve annulus by annuloplasty of the valve when said modified shape is obtained, wherein said annuloplasty implant comprises a helix-shaped loop structure configured to be positioned on either side of said valve to retain said modified shape of the annulus, wherein at least a portion of the helix-shaped loop structure conforms to a curvature of said annulus.